UnknownNot Applicable

Rezum for 30-80ml Patients With Moderate-severe LUTS to Study Surgical Principles for Median Lobe Enlargement

South Korea44 participantsStarted 2024-06-03

Plain-language summary

This study was created to determine the safety and efficacy of treating prostatic hyperplasia with or without prominent median lobe enlargement with the REZUM technique. The systematic implementation of decisions for the location, vapor time, and the number of injections contributes to the Rezum procedure configuration for the median lobe treatment being safer and standardizer.

Who can participate

Age range

50 Years – 85 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 50 to 85 years who have been diagnosed with benign prostatic hyperplasia at Seoul National University Hospital and are scheduled to undergo endoscopic surgery. * benign prostatic hyperplasia ≥ 30 and \< 80 ml * Patients who have given written informed consent to participate in the study according to their age * A urinary symptom score (International ProstateSymptom Score \[IPSS\] moderated (8-19 points) to severe (20-35 points) * Measured Postvoiding Residual (PVR) \<250 mL Exclusion Criteria: * History of prostate or bladder cancer, neurogenic bladder, bladder calculus, or clinically significant bladder diverticulum * Active infection, treatment for chronic prostatitis * Diagnosis of urethral stricture, meatal stenosis or bladder neck contracture, damaged external urinary sphincter, stress urinary incontinence, post-void residual \>300 mL or urinary retention, or prior prostate surgery * Men taking anticoagulants or on bladder anticholinergics or with severe cardiovascular disease * PSA greater than 4.0 ng/ml (unless prostate cancer was ruled out by biopsy) * Allergy to device materials, immune suppressants or corticosteroids use, and serious medical or mental illness.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

age

Timeframe: prior to procedure

Gender

Timeframe: prior to procedure

height

Timeframe: prior to procedure

weight

Timeframe: prior to procedure

Medical history

Timeframe: prior to procedure

Surgical history

Timeframe: prior to procedure

Date of consent

Timeframe: prior to procedure

Eastern Cooperative Oncology Group

Timeframe: prior to procedure

Trial details

NCT IDNCT06177821

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-17

View on ClinicalTrials.gov More Prostatic Hyperplasia of the Medial Lobe trials

Plain-language summary

Who can participate

Age range

50 Years – 85 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

age

Timeframe: prior to procedure

Gender

Timeframe: prior to procedure

height

Timeframe: prior to procedure

weight

Timeframe: prior to procedure

Medical history

Timeframe: prior to procedure

Surgical history

Timeframe: prior to procedure

Date of consent

Timeframe: prior to procedure

Eastern Cooperative Oncology Group

Timeframe: prior to procedure